FDA.reportPublic FDA data

WhiskCare 377

Product NDC
65585-356
Requested package NDC
65585-356-03
11-digit product format
655850356
Labeler code
65585
Product ID
65585-356_2206420a-400e-3a5f-e063-6394a90a49fd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Whisk Products, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-22
Marketing end
2027-08-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
WhiskCare 377

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038799Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
124b403f-d12e-6e5c-e063-6394a90a63f8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-356-01WhiskCare 37750 mL in 1 BOTTLE, PUMPSOLUTION503
65585-356-02WhiskCare 37724 in 1 BOTTLESOLUTION243
65585-356-02WhiskCare 37750 mL in 1 BOTTLE, PUMPSOLUTION503
65585-356-03WhiskCare 377208198 mL in 1 DRUMSOLUTION2081983
65585-356-04WhiskCare 3771000 mL in 1 BAGSOLUTION10003
65585-356-04WhiskCare 3774 in 1 BOXSOLUTION43
65585-356-05WhiskCare 3778 in 1 BOXSOLUTION83
65585-356-05WhiskCare 3771000 mL in 1 BAGSOLUTION10003
65585-356-06WhiskCare 377550 mL in 1 BOTTLE, PUMPSOLUTION5503
65585-356-06WhiskCare 3776 in 1 BOXSOLUTION63
65585-356-07WhiskCare 3776 in 1 BOXSOLUTION63
65585-356-07WhiskCare 3771750 mL in 1 BOTTLE, PUMPSOLUTION17503
65585-356-08WhiskCare 3773785 mL in 1 BOTTLE, PLASTICSOLUTION37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-356WHISKCARE 377 (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]3Current NDC, 13 package rows20240915_124b403f-d12e-6e5c-e063-6394a90a63f8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WhiskCare 377BENZALKONIUM CHLORIDEWhisk Products, Inc.124b403f-d12e-6e5c-e063-6394a90a63f82024-09-13WarningsExact identifier
ndc (package): 65585-356-03
ndc (product): 65585-356
ndc11 (package): 65585035603

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN124b403f-d12e-6e5c-e063-6394a90a63f83
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD124b403f-d12e-6e5c-e063-6394a90a63f83
1038799benzalkonium chloride 0.1 % Topical FoamSY124b403f-d12e-6e5c-e063-6394a90a63f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65585-356-0365585035603208198 mL in 1 DRUM (65585-356-03) 208198 ml2024-02-222027-08-01NoNoHistorical